MIA Lab Scientist
Summary
A lab scientist at a biotech company conducts advanced testing, method development, and data analysis to support research, quality, and production, while ensuring compliance with regulatory standards.
About the Company
The Lab Scientist is an experienced contributor responsible for executing advanced laboratory testing, method development, data analysis, and documentation to support research, quality, and production initiatives. This role builds on foundational laboratory skills by incorporating deeper scientific expertise, troubleshooting capabilities, and increased ownership of laboratory processes. The Lab Scientist serves as a strong technical resource within the lab, supporting complex testing, optimizing methodologies, ensuring data integrity, and contributing to continuous improvement initiatives. While this role does not have direct reports, it provides guidance and mentorship to Lab Specialists and collaborates closely with cross-functional teams.
About the Role
The Lab Scientist is responsible for executing advanced laboratory testing, method development, data analysis, and documentation to support research, quality, and production initiatives.
Responsibilities
Laboratory Testing & Analysis
- Perform advanced microbiological, chemical, and analytical testing with a high degree of accuracy and independence.
- Design and execute experiments to support R&D, quality investigations, and process improvements.
- Analyze complex datasets, interpret results, and provide actionable insights and recommendations.
- Ensure integrity, reliability, and reproducibility of test results.
Method Development & Optimization
- Develop, validate, and optimize laboratory methods in alignment with regulatory and industry standards.
- Troubleshoot analytical methods, instrumentation, and processes to improve efficiency and accuracy.
- Support method transfers, verifications, and continuous improvement of lab procedures.
Equipment & Instrumentation
- Operate, maintain, and troubleshoot advanced laboratory instrumentation (e.g., HPLC, ICP-OES, GC, LC-MS, spectrometers).
- Lead calibration, verification, and preventative maintenance activities for assigned equipment.
- Partner with the Lab Manager on equipment selection, qualification, and lifecycle management.
Documentation & Compliance
- Maintain detailed and accurate laboratory documentation, including test records, protocols, and reports.
- Review/write notebooks, documentation and reports.
- Ensure compliance with GMP, GLP, ISO, and internal quality standards.
- Support audits, inspections, and investigations by providing technical expertise and documentation.
Quality & Continuous Improvement
- Participate in root cause analysis, deviations, and CAPA activities.
- Identify opportunities to improve lab processes, workflows, and data quality.
- Support implementation of Quality Management System (QMS) initiatives.
Collaboration & Technical Leadership
- Serve as a subject matter expert (SME) in assigned testing areas or methodologies.
- Provide guidance, training, and mentorship to Lab Specialists and junior staff.
- Collaborate with R&D, Quality, and Production teams to support product development and issue resolution.
- Contribute to technical reports, presentations, and cross-functional projects.